If you or a loved one underwent a medical procedure that involved the use of transvaginal mesh and have started experiencing some side effects, it is important to know that you may have grounds to file a transvaginal mesh lawsuit against Johnson & Johnson or other distributors or manufacturers of these products.
A lawsuit will help you recover compensation if a defective medical device caused you harm. In many cases, however, you will need to work with an experienced personal injury attorney to get the compensation that you are entitled to.
Rueb Stoller Daniel has knowledgeable legal professionals that can help with your transvaginal mesh lawsuit and always offer free consultations to our clients. To learn more, contact us today online or via phone at 1-866-CALL-RSD.
What’s Transvaginal Mesh?
Transvaginal Mesh is also referred to as bladder slings or pelvic mesh and is a mesh device that’s implanted surgically used for treating stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women.
POP occurs when the muscles responsible for holding the pelvic organs in place become weakened thus resulting in bladder prolapse or dropping and pressing against the vaginal walls. SUI occurs if an activity such as sneezing or coughing causes the leakage of urine out of the urethra.
The vaginal mesh is used for repairing the issues above by providing additional support to the damaged or weakened tissue. It is typically made from either biologic material or porous synthetic material.
Surgical mesh has been in use since back in the 1950s, but it only started being used for treating abdominal repair of SUI in the 1990s. The product was approved for use in the transvaginal repair of POP in 2002 to reduce the POP relapse rate following traditional surgical procedures.
The product, however, soon started causing issues and women started suffering debilitating side effects. A study conducted in 2017 suggested that up to 40 percent of women suffer injuries due to the instruments used for implanting transvaginal mesh.
Synthetic transvaginal mesh has edges that sometimes pierce the surrounding tissue and can even puncture the bowel, uterus, or bowel. The sling may also migrate and in the process end up doing irreparable damage as it moves along. The mesh can also cause women to suffer nasty infections.
The synthetic mesh didn’t undergo any serious safety review by the FDA or even other regulatory agencies before manufacturers introduced it into the market. The most prominent of those manufacturers are Boston Scientific, American Medical Systems, C.R. Bard, Cook Medical, Coloplast, and Ethicon (a Johnson & Johnson subsidiary).
How is Transvaginal Mesh Surgery Carried Out?
Transvaginal mesh surgery is done through the insertion of surgical mesh via the vagina as opposed to via the abdomen. While abdominal mesh surgery has its issues, it is still considered a much safer option than transvaginal mesh surgery, which has been linked to serious, debilitating complications for thousands of women.
The FDA warned of complications linked to transvaginal mesh implants back in 2008. The FDA kept expressing concerns and issuing warnings, with the most recent one being on January 4th, 2016 where transvaginal mesh surgery for treating POP was reclassified by the FDA from moderate risk to high risk.
The unfortunate reality, however, is that the reclassification was done after hundreds of thousands of women had already received transvaginal mesh implants. For the vast majority of those women, the damage is already done.
What Are the Injuries Associated with Transvaginal Mesh?
The injuries that women allegedly have suffered from the mesh implant are debilitating and severe and could potentially have been avoided but only if those people had the right information.
The edges of the sling/mesh can easily cut through the skin after implantation thus cutting into nearby structures and causing infections and sometimes even puncturing the uterus, bowel, and bladder.
Complications from such infections can include back pain, UTI, extreme pain during intercourse, incontinence, inability to walk, etc. Some of the infections can spread through the entire body thus leading to death.
According to studies, the actual rate of injury is likely to increase considerably, which is hardly surprising since there are over 100,000 such procedures done every year. Reports made to the FDA suggest that there could be tens of thousands of injuries and hundreds of deaths.
Still, the injuries may take up to several years to develop after the initial surgery. Tens of thousands of women have filed lawsuits alleging that pelvic mesh products caused the injury.
Unfortunately, close to 30 percent of women that underwent mesh surgery for POP will require another related surgery.
Due to the high risk of complications, vaginal mesh used for treating POP has been re-classified by the FDA as a high-risk device. However, the classification doesn’t apply to vaginal mesh used for repairing SUI. Still, many surgeons have ceased using vaginal mesh completely due to the associated risks.
Safer synthetic mesh alternatives exist, such as biological mesh, which should be considered before deciding to use synthetic materials.
How Can One Avoid Transvaginal Mesh Injury?
Women that have these products in their bodies need to know of the symptoms that indicate movement of the mesh so that they can tell when medical care is needed. If you suffer from any symptoms or complications that you think could be related to a mesh implant placement, let your physician known immediately. The most important thing to do is following the advice of a qualified physician.
Failed mesh implants almost always require surgery to remove them. However, this is not as easy as one might assume.
Is It Possible to Remove Pelvic Mesh?
Once implanted, the mesh is incredibly difficult to remove. Doctors are sometimes unable to remove all the mesh even after multiple surgeries since by that point it has already become infused with the surrounding tissue thus causing severe pain and life-long problems.
Who is the Manufacturer of Vaginal Mesh?
- C.R. Bard
- Boston Scientific
- American Medical Systems (now a Unit of Endo Pharmaceuticals)
- Johnson & Johnson
The 4 manufacturers above are all regarded as the leading manufacturers of transvaginal products in the U.S.A. Together, they face thousands of lawsuits.
Has There Ever Been a Transvaginal Mesh Recall?
Transvaginal mesh hasn’t been recalled to this date, but on January 4, 2016, the transvaginal mesh used in the repair of POP was reclassified by the FDA as Class III high-risk devices. Class III is the highest risk category the FDA has when it comes to medical devices.
Thousands of lawsuits have been filed by women that received the transvaginal mesh against the manufacturers. The recipients suffered chronic pain, serious and debilitating injuries, and often have undergone several surgeries with varying levels of success to correct the damage or for the removal of transvaginal mesh implant and prevent further injury.
Doctors would in the past use other options when it came to repairing POP and SUI. The FDA now strongly recommends going back to those methods whenever possible since the risks associated with transvaginal mesh are far greater than any possible benefits.
The FDA recommends that doctors need to understand that it is possible to treat POP without the use of mesh. In addition, doctors need to inform patients if the mesh is being used. Patients should also be assertive when it comes to knowing why a Class III medical device is needed and what other options are available.
Have Any Transvaginal Mesh Lawsuits Been Filed?
Yes. Tens of thousands of lawsuits have actually been filed by women that received the transvaginal mesh against manufacturers. The recipients suffered chronic pain, serious and debilitating injuries, and in most instances, have undergone several surgeries with varying levels of success to correct the damage or for the removal of transvaginal mesh implant and prevent further injury.
A lawsuit that was filed against Boston Scientific makes the allegation that the company actually used counterfeit resin from China in its vaginal mesh after a name-brand manufacturer stopped supplying resin for permanent implants because of safety concerns. If such allegations are found to be true, Boston Scientific is likely to face criminal charges.
How Can a Transvaginal Mesh Attorney Help?
If you have suffered any discomfort or injury after getting a transvaginal mesh implant, you should consider joining thousands of other women that have chosen to hold pharmaceutical manufacturers are probably even others, accountable for their suffering and injuries that the transvaginal mesh devices have might have caused. You could have grounds for legal action on the basis of product liability law for:
- Breach of Warranty
- Strict Liability
Depending on the jurisdiction where you file the lawsuit and the facts of your case, you could also have other causes for legal action. You may be entitled to recover damages for:
- Loss of consortium
- Medical bills
- Lost wages
- Pain and suffering
- Perhaps punitive damages (to discourage similar behavior and punish wrongdoers)
Federal courts haven’t awarded class-action status to transvaginal mesh litigation, but many of the lawsuits have been consolidated into multidistrict litigation (MDL). The advantage of this is that pretrial motions in similar cases (i.e. individual transvaginal mesh lawsuits) are heard by a federal judge who rules on at least 1 legal question, to narrow the scope of discovery and pretrial motions for the purpose of streamlining lawsuits to ensure that they never drag on for too long.
After the MDL judge has ruled on the common legal issues in the lawsuits, the cases are then remanded back to the original courts for trial at the discretion of the Judicial Panel on MDL that controls the proceeding.
Once a federal judge rules on common legal issues relating to multiple transvaginal mesh lawsuits, the litigation process can be more focused when it comes to individual cases. That allows the jury to bypass the complex legal issues and instead hear and rule on questions of the fact that are different in your case, such as how you were physically injured by the transvaginal mesh implant and what damage the injury did to your life.
Contact our Transvaginal Mesh Lawyers for a Free Review of Your Case
If you have suffered infection, pain, prolapse, recurrence of incontinence, or any other side effects that are caused by defective surgical mesh, contact Rueb Stoller Daniel today. You deserve to be compensated for your pain and suffering.
You can call us at 1-866-CALL-RSD today to schedule your no-risk, free case evaluation. We know and understand the complex world of pharmaceutical laws and will help you get the justice that you deserve. You can count on us to help. Fill out the online contact form or call us now!